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Last Updated: December 12, 2025

Suppliers and packagers for generic pharmaceutical drug: ALPRAZOLAM


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ALPRAZOLAM

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Hikma ALPRAZOLAM alprazolam CONCENTRATE;ORAL 074312 ANDA Hikma Pharmaceuticals USA Inc. 0054-3068-44 1 BOTTLE in 1 CONTAINER (0054-3068-44) / 30 mL in 1 BOTTLE 1993-10-31
Actavis Elizabeth ALPRAZOLAM alprazolam TABLET, EXTENDED RELEASE;ORAL 078056 ANDA Actavis Pharma, Inc. 0228-3083-06 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (0228-3083-06) 2007-03-12
Actavis Elizabeth ALPRAZOLAM alprazolam TABLET, EXTENDED RELEASE;ORAL 078056 ANDA Actavis Pharma, Inc. 0228-3084-06 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (0228-3084-06) 2007-03-12
Actavis Elizabeth ALPRAZOLAM alprazolam TABLET, EXTENDED RELEASE;ORAL 078056 ANDA Actavis Pharma, Inc. 0228-3086-06 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (0228-3086-06) 2007-03-12
Actavis Elizabeth ALPRAZOLAM alprazolam TABLET, EXTENDED RELEASE;ORAL 078056 ANDA Actavis Pharma, Inc. 0228-3087-06 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (0228-3087-06) 2007-03-12
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers for the Pharmaceutical Drug: ALPRAZOLAM

Last updated: July 27, 2025

Introduction

Alprazolam, a potent benzodiazepine, is widely prescribed for managing anxiety disorders and panic attacks. Its high demand in healthcare sectors has fostered an extensive supply chain comprising manufacturers, distributors, and authorized pharmacies. Understanding the landscape of Alprazolam suppliers is vital for pharmaceutical companies, healthcare providers, and regulatory authorities to ensure drug authenticity, compliance, and continuous patient access.


Global Manufacturing and Leading Suppliers

1. Major Pharmaceutical Manufacturers

Several large pharmaceutical corporations are at the forefront of Alprazolam production:

  • Pfizer Inc.
    Historically one of the primary producers, Pfizer manufactured and marketed Alprazolam under the brand name Xanax. Although Pfizer has divested some assets, its legacy manufacturing facilities continue to produce Alprazolam for licensed markets.

  • Joint Stock Company “Pharmaceutical Factory” (Russia)
    This regional producer supplies Alprazolam within the Eurasian Economic Union. Their medicinal products adhere to stringent regulatory standards, making them reputable sources in their territories.

  • Sun Pharmacare (India)
    An emerging manufacturer that supplies Alprazolam to South Asian markets, following Good Manufacturing Practices (GMP) standards, and often offers competitive pricing.

  • MediChem Pharmaceuticals (India)
    Focuses on bulk chemical synthesis of Alprazolam API, exporting to various contract manufacturers globally.

2. Generic Manufacturers

The generic market for Alprazolam is extensive, featuring numerous manufacturers, especially in regions with flexible regulatory frameworks:

  • Dr. Reddy’s Laboratories (India)
    Offers certified generics for domestic and export markets; supplies are widely available, supported by their robust API production.

  • Lupin Limited (India)
    Manufactures both Alprazolam APIs and finished dosage forms, providing competitive options worldwide.

  • Torrent Pharmaceuticals (India)
    Known for producing high-quality generics, including Alprazolam, serving diverse markets.

  • Teva Pharmaceuticals (Israel)
    A global generic giant, Teva produces Alprazolam formulations, especially for North American and European markets.


Suppliers in the Supply Chain: API and Finished Dosage Forms

1. API Suppliers

Active Pharmaceutical Ingredient (API) supply is critical for controlling quality. The primary API suppliers include:

  • Hetero Labs (India)
    Specializes in producing Alprazolam API with GMP certification, supplying both domestic and international brands.

  • Aurobindo Pharma (India)
    A prominent API producer offering bulk Alprazolam, meeting regulatory standards.

  • Famar Healthcare Services (Greece)
    Offers APIs and specializes in complex benzodiazepines.

2. Finished Dosage Manufacturers

Finished Alprazolam tablets are produced by:

  • Mylan (USA)
    Manufactures Alprazolam under strict regulatory standards, exported globally.

  • Endo Pharmaceuticals (USA)
    Offers Alprazolam formulations, with a focus on branded prescriptions.

  • Aventis Pharma (France)
    Historically associated with Xanax, now part of Sanofi, continues to supply some European markets.


Distribution Networks and Suppliers

  • Authorized Distributors
    Major pharmaceutical distributors such as McKesson, Cardinal Health, and Cencora distribute Alprazolam in North America. Authorized regional distributors in Europe and Asia maintain compliance with local regulatory authorities.

  • Online Suppliers and Dark Web Markets
    A significant proportion of Alprazolam is available via unregulated online pharmacies or black markets, posing challenges for regulation and quality assurance. These sources often lack proper GMP certifications, increasing risks of adulterated or counterfeit products.


Regulatory and Quality Considerations

Due to Alprazolam's controlled status in many regions, suppliers must adhere to stringent regulations:

  • Good Manufacturing Practices (GMP)
    Confirmed supplier compliance with GMP ensures product purity, potency, and safety.

  • Licensing and Certification
    Suppliers must hold relevant licenses from regulatory agencies like the FDA (USA), EMA (Europe), or equivalent authorities in their regions.

  • Counterfeit Risks and Quality Assurance
    The high demand for Alprazolam has led to counterfeit proliferation. Authorities advise procurement solely from verified, licensed suppliers. Analytical testing and barcoding are recommended for authenticity verification.


Emerging Trends and Future Outlook

  • Increased Contract Manufacturing
    Many brand-name companies outsource Alprazolam production to contract manufacturing organizations (CMOs) to reduce costs and enhance supply chain flexibility, especially during pandemic-induced disruptions.

  • Regional Production Boosts
    Countries like India and China continue expanding API and finished product manufacturing, aiding in global supply stability, yet also raising concerns about quality control enforcement across regions.

  • Regulatory Harmonization
    Efforts towards harmonizing pharmaceutical regulations aim to streamline supplier qualification processes, reducing delays and ensuring consistent quality standards globally.


Conclusion

The supply chain for Alprazolam encompasses a broad spectrum of manufacturers and distributors, primarily concentrated in India, the USA, and Europe. While authorized pharmaceutical companies uphold rigorous quality standards, market demand also attracts unregulated sources, raising concerns regarding product authenticity and safety. Ensuring procurement from reputable, licensed suppliers with proven GMP compliance remains essential for stakeholders to mitigate risks associated with counterfeit or substandard products.


Key Takeaways

  • Top Alprazolam suppliers include established multinational pharmaceutical companies and reputable generic manufacturers, primarily based in India, the USA, and Europe.

  • API production is concentrated among certified manufacturers adhering to GMP standards, while finished dosage forms are supplied globally by major pharmaceutical firms.

  • The supply chain faces challenges from unregulated online sources, emphasizing strict procurement practices and verification.

  • Increased regional manufacturing and regulatory harmonization aim to bolster supply stability and product quality assurance.

  • Due diligence, including supplier licensing verification and analytical testing, is vital to safeguard against counterfeit products.


FAQs

1. Who are the leading global suppliers of Alprazolam?
Major suppliers include Pfizer, Dr. Reddy’s Laboratories, Lupin, Torrent Pharmaceuticals, Mylan, and Teva, producing both APIs and finished formulations under strict regulatory oversight.

2. Is Alprazolam available from generic manufacturers?
Yes. Generics from companies like Dr. Reddy’s, Lupin, Torrent, and Teva constitute a significant portion of the global supply, often at lower costs without compromising quality.

3. How can buyers verify the legitimacy of Alprazolam suppliers?
By confirming licensing and GMP certification from relevant regulatory authorities, purchasing from authorized distributors, and utilizing analytical testing methods for product verification.

4. Are there regions with limited Alprazolam supplier options?
Yes. Due to regulatory restrictions, some regions may have limited authorized suppliers, prompting reliance on importation or unregulated sources.

5. What future trends will impact Alprazolam supply?
Increased contract manufacturing, regional production expansion, and efforts toward regulatory harmonization will shape supply dynamics. However, ongoing risks from counterfeit products persist without strict verification measures.


References

  1. U.S. Food and Drug Administration (FDA). Drug Approvals and Quality Standards.
  2. European Medicines Agency (EMA). Market Authorization of Medicines.
  3. Pfizer Inc. Official Website. Product Portfolio.
  4. Indian Ministry of Chemicals and Fertilizers. Pharmaceutical Manufacturing Data.
  5. International Narcotics Control Board. Report on Benzodiazepine Production and Distribution.

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